Microsurgical Single Versus Double Dartos Flap in Distal Hypospadias Repair: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of the Uethrocutaneous fistula
研究概览
简要总结
This study aims to compare the surgical and functional outcomes of microsurgical single dartos flap versus double dartos flap in distal hypospadias repair.
详细描述
Hypospadias is recognized as a frequent congenital defect of the male urogenital system, with its prevalence exhibiting significant regional and ethnic disparities globally.
Despite continuous improvements in surgical methodology, the development of a urethrocutaneous fistula (UCF) remains a persistent and difficult postoperative challenge. Reported UCF rates fluctuate between 1% and over 20%, heavily influenced by factors such as the initial position of the meatus, the specific surgical approach, and the practitioner's level of expertise.
Expanding on the use of a single-layer dartos flap (SDF), recent research has focused on whether a double-layer dartos flap (DDF) provides enhanced protection against fistula formation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male patients diagnosed with Distal Hypospadias.
- •Age: From 6 months to 18 years.
- •Primary cases.
- •Uretheral Plate>8mm.
- •Glanular width≥14mm.
排除标准
- •Coronal and glanular hypospadias.
- •Severe chordee.
- •Associated disorders of sexual development.
- •Un-controlled bleeding disorders.
结局指标
主要结局
Incidence of the Uethrocutaneous fistula
时间窗: 6 months after surgery
Incidence of the Uethrocutaneous fistula will be recorded.
次要结局
- Incidence of the meatal stenosis(6 months after surgery)
- Wound infection rate(6 months after surgery)
- Overall complication rate(6 months after surgery)
- Cosmetic appearance(6 months after surgery)
研究者
Ahmed Megahed Mohamed Goda
Resident of Urology, Faculty of Medicine, Tanta University, Egypt.
Tanta University